Project Bronson cumulative irritancy study, (non-occlusive).

• Research type

  Research Study

• Full title

  A randomised, double-blind, non-occlusive comparative study to determine the cutaneous irritancy of four new 5% Ibuprofen gel formulations in healthy volunteers.

• IRAS ID

  89144

• Contact name

  Alexander J Thompson

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd

• Eudract number

  2011-003691-37

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Reckitt Benckiser have developed a locally-applied, locally-acting Ibuprofen topical gel for over the counter, (OTC), treatment of non-serious, localised pain in the adult population.The purpose of this study is to determine the skin reaction potential to repeated applications, (cumulative irritancy potential), of four new Ibuprofen gel formulations when applied under non-occlusive conditions.Whilst there is no evidence that topical Ibuprofen applied under non-occlusive conditions is a significant topical irritant on repeated use, (the range of approved Ibuprofen topical products is testimony to this), these are four new formulations and therefore, it is considered appropriate to confirm that it is safe in respect of irritancy.The study has been designed to reflect the anticipated application schedule, (ie, administered according to typical, on-pack, instructions for Ibuprofen gel products). The Ibuprofen gels will therefore be applied to designated areas of the subjects backs three times a day for 21 consecutive days.Dermal irritancy scores will be recorded prior to each application to give an indication of the cumulative irritancy of the products. The primary endpoint will be the skin reaction mean scores at each of the sixty four skin assessments, calculated from the individual assessments recorded by the assessor. Throughout the study, Adverse Events and concomitant medications will be sought.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0161

• Date of REC Opinion

  25 Oct 2011

• REC opinion

  Further Information Favourable Opinion